510(k) K110183

ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE by Arthrocare Corp. — Product Code NDN

K110183 is an FDA 510(k) premarket notification submitted by Arthrocare Corp. for the device "ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE". The FDA issued a decision of Substantially Equivalent on February 16, 2011. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Arthrocare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2011
Date Received
January 21, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type